Devices

Device Recall Datascope

  • Model / Serial
    REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
  • Product Description
    10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
  • Manufacturer
    Datascope Corp
  • 1 Event

Manufacturer

Datascope Corp
  • Manufacturer Address
    Datascope Corp, 15 Law Drive, Fairfield NJ 07004-3206
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Datascope System 98/98xt, CS 100/CS100i and CS 300 IntraAortic Balloon Pump
  • Model / Serial
    IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and approximately 104 countries.
  • Product Description
    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division
Device Recall DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP ...
  • Model / Serial
    Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- states of IL and FL.
  • Product Description
    Low-Level Output Cable. || The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
  • Manufacturer
    Datascope Corporation